OncoMatch/Clinical Trials/NCT06545682
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
Is NCT06545682 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Alpelisib + Pembrolizumab for melanoma (skin cancer).
Treatment: Alpelisib + Pembrolizumab — To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
TNBC patients (defined as ER <1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative)
Required: HER2 (ERBB2) 0, 1+, 2+ and FISH negative (0, 1+, 2+ and FISH negative)
TNBC patients (defined as ER <1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative)
Disease stage
Metastatic disease required
locally advanced, unresectable, or metastatic melanoma or TNBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Melanoma patients ... who have progressed on an anti-PD-1 or anti-PD-L1-based regimen
Must have received: anti-PD-L1 therapy
Melanoma patients ... who have progressed on an anti-PD-1 or anti-PD-L1-based regimen
Cannot have received: chemotherapy or radiotherapy
Exception: within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment
Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment
Lab requirements
Blood counts
Adequate organ function as defined in Table 2
Kidney function
Adequate organ function as defined in Table 2
Liver function
Adequate organ function as defined in Table 2
Has adequate organ function as defined in Table 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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